Pulmovent Combi solution for inhalation (0.5mg+0.25mg)/ml 20ml №1

Name:
Pulmovent Combi solution dingal. (0.5mg + 0.25mg)ml 20ml vial in pack No. 1
Description:
Transparent colorless or almost colorless liquid. Virtually odorless. The main active ingredient Ipratropium bromide + fenoterol Release form Solution Dosage 20 ml Pharmacological properties PULMOVENT® COMBI ? a combined preparation containing two active ingredients with a bronchodilatory effect: ipratropium bromide? M-holinoblokator and fenoterol hydrobromide? ?-adrenergic agonist. Fenoterol relaxes the smooth muscles of the bronchi and blood vessels, and also prevents the development of bronchospasm. Fenoterol affects cardiac activity. When taken in high doses, there is an effect on metabolism: an increase in blood glucose, a decrease in the level of potassium in the blood, lipolysis, glycogenolysis. In high concentrations, it inhibits the contractile activity of the uterus. Ipratropium bromide effectively eliminates bronchospasm associated with the influence of the vagus nerve, reduces the secretion of glands (including bronchial). When inhaled, it causes bronchodilation, mainly due to local rather than systemic action. It does not adversely affect the secretion of mucus in the respiratory tract, mucociliary clearance and gas exchange. With the combined use of fenoterol hydrobromide and ipratropium bromide, the bronchodilator effect is achieved through various mechanisms. These active substances complement each other, as a result of which the antispasmodic effect on the muscles of the bronchi is enhanced and a greater breadth of therapeutic action is provided for bronchopulmonary diseases accompanied by impaired airway patency. Indications for use Prevention and symptomatic treatment of chronic obstructive respiratory diseases: bronchial asthma (BA) (allergic and non-allergic), exercise asthma, chronic obstructive pulmonary disease (COPD). With prolonged therapy, it is necessary to prescribe concomitant anti-inflammatory therapy. Dosage and administration Inhalation. 1 ml of PULMOVENT® COMBI contains 250 µg anhydrous ipratropium bromide and 500 µg fenoterol hydrobromide 24 drops = 1 ml. The dose should be selected individually. During treatment, patients should be under medical supervision. Treatment at home is possible only after consultation with a doctor in a situation where a fast-acting ?-agonist at a low dose is ineffective. In the absence of other prescriptions, the following dosing regimens are recommended (therapy should always be started with the minimum recommended dose). Adults (including the elderly) and children over the age of 12 Acute attacks of bronchial asthma: For mild and moderate attacks, 1 ml (24 drops) of PULMOVENT® COMBI is used. In severe cases, with the ineffectiveness of the above dose, up to 2.5 ml (60 drops) are used. In especially severe cases, under medical supervision, it is possible to use doses up to 4 ml (96 drops). When conducting lung ventilation as an aid, the recommended dose is 0.5 ml (12 drops). Children aged 6 ? 12 years Acute attacks of bronchial asthma: For quick relief of symptoms, 0.5 ? 1 ml (12 x 24 drops). In severe cases, apply up to 2 ml (48 drops). For the prevention of asthma attacks of physical effort or in case of expected contact with an allergen, it is recommended to use 0.1? 0.2 ml (2 x 5 drops) followed by a dilution of 2 x 3 milliliters of saline, for 10? 15 minutes before exercise/contact. Children under 6 years of age Given the limited information on the use of the drug in this age group, the use of the drug is possible in the doses described below only under medical supervision: 0.1 ml (2-3 drops) per kg of body weight, up to a maximum of 0.5 ml ( 12 drops), followed by dilution with saline to a volume of 3? 4 ml. Rules for the use of the drug PULMOVENT® COMBI solution for inhalation is intended only for inhalation (using an appropriate nebulizer), it must not be used orally. PULMOVENT® COMBI inhalation solution must not be diluted with distilled water. The recommended dose is diluted with 0.9% sodium chloride solution to a volume of 3? 4 ml. The solution must be diluted each time immediately before use; any remaining diluted solution must be disposed of. The duration of inhalation can be controlled by the consumption of the diluted volume of the solution. PULMOVENT® COMBI solution for inhalation can be used with various models of nebulizers. The dose reaching the lungs and the systemic dose depend on the type of nebulizer used. In cases where a wall-mounted oxygen apparatus is available, the solution is best applied at a flow rate of 6? 8 liters per minute. Patients should follow the manufacturer’s instructions for use of the nebulizer Use during pregnancy and lactation Pregnancy In preclinical studies, no direct or indirect negative effects of fenoterol and ipratropium on pregnancy, embryonic / fetal development, childbirth or postnatal development have been identified. Caution should be exercised when using PULMOVENT® COMBI during pregnancy. In the first and third trimester of pregnancy, the drug is contraindicated. The drug should be used with caution in the second trimester. The inhibitory effect of fenoterol on the contractile function of the myometrium should be taken into account. In general, for short-acting ?-adrenergic agonists, there is still no evidence of an increased risk of birth defects. The use of α2-agonists at the end of pregnancy or at high doses may have adverse effects on newborns (tremor, tachycardia, impaired glucose metabolism, hypokalemia). Breastfeeding Fenoterol hydrobromide passes into breast milk. There are no data on the penetration of ipratropium bromide into breast milk. Caution should be exercised when prescribing PULMOVENT® COMBI to breastfeeding women. There are no clinical data on the effect of the combination of ipratropium bromide and fenoterol hydrobromide on fertility. Preclinical studies of the effects of individual components have not shown adverse effects on fertility. Use in children The drug is prescribed to children in the recommended doses. The use of fenoterol hydrobromide and ipratropium bromide in children under 6 years of age is possible only under medical supervision. Precautions In case of sudden rapid increase in shortness of breath (difficulty breathing), you should immediately consult a doctor. When using the drug, a hypersensitivity reaction may develop, in rare cases, urticaria, Quincke’s edema, rash, bronchospasm, oropharyngeal edema, anaphylaxis appear. Conditions in which PULMOVENT® COMBI should be used only after a thorough risk/benefit assessment, especially in cases where the dose exceeds the recommended one: poorly controlled diabetes mellitus; ? recent myocardial infarction; ? severe organic diseases of the heart or blood vessels; ? hyperthyroidism; ? pheochromocytoma. Patients with severe cardiac pathology (for example, coronary heart disease, arrhythmias or severe heart failure) who are taking PULMOVENT® COMBI should consult a doctor if they develop chest pain or other symptoms of worsening heart function. You should pay attention to symptoms such as shortness of breath and chest pain, because. the cause of their occurrence can be both disorders of the bronchopulmonary system and the heart. PULMOVENT® COMBI, as well as other anticholinergics, should be used with caution in patients with benign prostatic hyperplasia or bladder neck obstruction, in patients with a tendency to develop angle-closure glaucoma. Complications from the organ of vision (mydriasis, increased intraocular pressure, angle-closure glaucoma, eye pain) are possible if an aerosol of the drug enters the eyes. Patients should be instructed on the correct use of the inhalation solution. Pain and discomfort in the eye, blurred vision, visual halos or color images in association with redness of the eyes due to conjunctival hyperemia and corneal edema may be signs of an acute attack of angle-closure glaucoma. If such symptoms occur, the patient should immediately contact a specialist. Long-term use of the drug In patients with BA, PULMOVENT® COMBI should be used only when necessary. For patients with mild COPD, on-demand (symptomatic) treatment may be preferable to regular use. To control airway inflammation and to prevent worsening of the disease in patients with asthma or COPD responding to steroids, the need to use or increase anti-inflammatory therapy should be remembered. Regular use of high doses of a drug containing α2-agonists to relieve symptoms of bronchial obstruction may cause deterioration in disease control. With increased bronchial obstruction, simply increasing the dose of α2-agonists above the recommended one for a long time is not only not justified, but also dangerous. To prevent a life-threatening worsening of the course of the disease, it is necessary to decide on the revision of the patient’s treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids. Other sympathomimetic bronchodilators should be administered simultaneously with PULMOVENT® COMBI only under medical supervision. With the use of β2-agonists, potentially dangerous hypokalemia may develop. Patients with cystic fibrosis may have gastrointestinal motility disorders. In rare cases, an increase in blood glucose levels is possible. In this regard, it is recommended to control blood glucose levels in patients with diabetes mellitus. PULMOVENT® COMBI solution for inhalation contains the preservative benzalkonium chloride and the stabilizer disodium edetate. These components may cause bronchospasm in patients with airway hyperreactivity. In athletes, the use of the drug due to the presence of fenoterol in its composition can lead to positive results in doping tests. Influence on the ability to drive vehicles and other complex mechanisms There are no data on the effect of fenoterol hydrobromide and ipratropium bromide on the reaction rate when driving vehicles or operating other mechanisms. However, patients should be informed about undesirable effects such as dizziness, tremor, disturbance of accommodation, dilated pupils and blurred vision, which may occur during treatment with PULMOVENT® COMBI. Therefore, care should be taken when driving vehicles or working with other complex mechanisms. In the event of any of the side effects mentioned above, patients should avoid these activities. Interaction with other drugs?-agonists, anticholinergics and xanthine derivatives (for example, theophylline) may enhance the bronchodilatory effect of PULMOVENT® COMBI. With the simultaneous use of other α-agonists, systemic anticholinergics, xanthine derivatives (for example, theophylline), side effects may increase. Hypokalemia caused by the use of α2-adrenergic agonists can be enhanced with simultaneous use with xanthine derivatives, corticosteroids and diuretics. In the treatment of patients with severe forms of obstructive airways disease, this fact should be given special attention. Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia can enhance the negative effect of hypokalemia on heart rate. In such cases, it is recommended to control the level of potassium in the blood serum. Be careful when prescribing ?2-adrenergic agonists to patients receiving MAO inhibitors and tricyclic antidepressants, tk. these drugs are able to enhance the action of ?-adrenomimetic agents. Simultaneous use of β-blockers may reduce the bronchodilator effect of PULMOVENT® COMBI. Inhaled halogenated anesthetics (eg, halogen, trichlorethylene, or enflurane) may increase the effect of ?2-adrenergic agonists on the cardiovascular system. Contraindications hypersensitivity to fenoterol hydrobromide and / or ipratropium bromide, atropine-like substances, as well as excipients of the drug; hypertrophic obstructive cardiomyopathy; tachyarrhythmia; I and III trimesters of pregnancy. Composition Active substances: 1 ml of inhalation solution contains 0.5 mg of fenoterol hydrobromide and 0.261 mg of ipratropium bromide in the form of monohydrate (which corresponds to 0.25 mg of anhydrous ipratropium bromide). Excipients: sodium chloride, disodium edetate, benzalkonium chloride, concentrated hydrochloric acid, purified water. Overdose Symptoms of overdose are usually associated mainly with the action of fenoterol. The following symptoms may be observed due to excessive stimulation of ?-adrenergic receptors: tachycardia, palpitations, tremor, increase or decrease in blood pressure. increased pulse pressure, angina pectoris, arrhythmias, a feeling of flushing to the face, a feeling of heaviness behind the sternum, increased bronchial obstruction. In addition, when using the drug according to registered indications in higher doses than recommended, the development of metabolic acidosis is possible. With an overdose of fenoterol, hypokalemia may occur, so it is necessary to control the level of potassium in the blood plasma. Possible symptoms of overdose due to the action of ipratropium bromide (such as dry mouth, disturbance of accommodation) are mild and transient, which is associated with a wide therapeutic range and topical application. Treatment: the use of sedatives, tranquilizers is recommended; in severe cases, intensive therapy is carried out. As a specific antidote, ?-blockers, preferably selective ?1-blockers, can be used. However, in patients with asthma or COPD, their dose should be carefully selected due to the risk of developing acute bronchospasm, which can be fatal. Side effects Most of the side effects listed below can be explained by the anticholinergic and ?-adrenergic properties of PULMOVENT® COMBI. As with other drugs used by inhalation, the drug may cause local irritation. The most common side effects include: cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, hoarseness, tachycardia, palpitations, vomiting, increased systolic blood pressure, and nervousness. The frequency of occurrence of adverse reactions is indicated as: very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from? 1/1000 to <1/100); rarely (from? 1/10000 to <1/1000); very rarely (< 1/10000, including isolated cases); unknown (cannot be determined from the available data). From the immune system: rarely? anaphylactic reactions, hypersensitivity. Metabolic disorders: rare ? hypokalemia; very rarely ? increase in blood glucose levels. Mental disorders: infrequently? nervousness; rarely ? agitation, mental disorders. From the side of the nervous system: infrequently? headache, tremor, dizziness; unknown? hyperactivity. On the part of the organ of vision: rarely? glaucoma, increased intraocular pressure, disturbance of accommodation, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, sensation of a halo before the eyes. From the side of the cardiovascular system: infrequently? tachycardia, rapid heartbeat; rarely ? arrhythmias, atrial fibrillation, supraventricular tachycardia, myocardial ischemia. From the respiratory system: often? cough; infrequently ? pharyngitis, dysphonia; rarely ? bronchospasm, sore throat, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dry throat. From the gastrointestinal tract: infrequently? nausea, vomiting, dry mouth; rarely ? stomatitis, glossitis, gastrointestinal motility disorders, diarrhea, constipation, swelling of the oral mucosa, heartburn. From the skin and subcutaneous tissue: rarely? urticaria, rash, itching, angioedema, hyperhidrosis. From the musculoskeletal system and connective tissue: rarely? muscle weakness, muscle spasm, myalgia. From the side of the kidneys and urinary system: rarely? urinary retention. Research: infrequently - an increase in systolic blood pressure; rarely - a decrease in diastolic blood pressure. Please report any side effects not listed in this leaflet to your doctor or pharmacist. Storage conditions Store in a place protected from light at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children! Buy Pulmovent Combi inhalation solution (0.5mg+0.25mg)/ml 20ml №1 for Pulmovent Combi solution for inhalation (0.5mg+0.25mg)/ml 20ml №1